Meclizine Hydrochloride

{
  "unii": {
    "unii": "HDP7W44CIO",
    "rxcui": "82041",
    "inchikey": "KDLHYOMCWBWLMM-UHFFFAOYSA-N",
    "display_name": "MECLIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52ee9258-8311-e6bd-e063-6294a90a567f": {
      "match": "brand_token",
      "title": "MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "80425-0494_2d31baa5-5e96-61fa-e063-6394a90a7413",
  "productndc": "80425-0494",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "010721",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jan 20, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MECLIZINE HYDROCHLORIDE",
  "proprietary_name": "Meclizine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA010721",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Meclizine Hydrochloride",
  "start_marketing_date": "20250202",
  "active_numerator_strength": "25"
}